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Back To Vidyya FDA Approves Malarone

For The Prevention And Treatment Of Malaria

As of 14-July-2000, The FDA has approved Malarone, a new combination drug for the prevention and treatment of acute, uncomplicated P. falciparum malaria. Malarone is a combination of atovaquone and proguanil HCL. Atovaquone is currently marketed in the United States under the trade name Mepron for pneumocystis carinii pneumonia. Proguanil was approved in the US in 1948 for use in malaria. Because it was not widely used in this country, it ceased to be marketed here in the 1970s. It continues to be used in combination with other drugs in Canada and a number of European countries.

Malarone has been shown to be effective in regions where resistance to other anti-malarial drugs has developed. Malaria is transmitted from person to person by the bite of an infected Anopheles mosquito. These mosquitoes are present in almost all tropical countries. Persons contemplating travel to certain endemic tropical areas should see their doctor and ask about malaria prevention.

The early symptoms of malaria include fever, chills, headache, muscle ache, and malaise. Without prompt treatment complications such as coma, kidney failure, and respiratory distress may occur resulting in death. Travelers who become ill with a fever during or after travel in an area of malaria transmission should seek prompt medical attention and inform their physician of their recent travel history.

Malarone was evaluated for the treatment of malaria in adults, children, partially immune, and non-immune individuals. Eight active- controlled clinical trials were conducted in countries in Africa, Asia, South America, and Europe. Overall efficacy in 521 evaluable patients was 98.7 percent.

Malaria can be prevented by the use of prophylactic antimalarial drugs and protection against mosquito bites through the use of protective clothing, insect repellents, and bednets.

Malarone was evaluated for the prophylaxis (prevention) of malaria due to P. falciparum in four clinical trials in Africa. Over a period of approximately 3 months, malaria occurred in 2 out of 279 patients who received Malarone. For those patients who were given a placebo, 92 out of 297 patients contracted malaria.

Additional information from challenge studies indicated that Malarone was effective against the early liver stage of malaria as well as the blood stage. The early liver stage is the form of the parasite before it appears in the blood and before symptoms, such as fever and chills, occur. A challenge study showed that Malarone is active against the early liver as well as the blood stage.

Among adults who received Malarone for treatment of malaria, the side effects included abdominal pain, nausea, vomiting and headache. Among pediatric patients, vomiting and itching were reported adverse reactions. In subjects given Malarone for prevention of malaria, the most commonly reported side effects were headache and abdominal pain.

Malarone should be taken at the same time each day with food or milk. In the event of vomiting, a repeat dose should be taken within 1 hour of dosing. For the treatment of adults with malaria, Malarone is given as a single dose of four tablets (total daily dose 1 g atovaquone/400 mg proguanil hydrochloride)for three consecutive days. The dose for prophylactic treatment with Malarone is one tablet (250 mg atovaquone/100 mg proguanil hydrochloride) per day for adults. Prophylactic treatment with Malarone should be started 1 or 2 days before entering a malaria-endemic area and continued daily during the stay and for 7 days after return. Body weight determines the dose for malaria treatment and prevention in children.

Malarone is manufactured by Glaxo Wellcome Inc. of Research Triangle Park, N.C.


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Editor: Susan K. Boyer, RN
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